This invention relates to a device for alleviating urinary incontinence. More particularly, the invention is concerned with a device which facilitates control of urination by preventing undesirable leakage of urine and yet allowing micturition when required without removal of the device from the body of the patient. A most preferred embodiment of the device is for alleviating urinary incontinence. particularly stress incontinence, in a female patient. An embodiment for use with a male patient is also included. A further embodiment for dealing with leakage from a body stoma is also contemplated.
Urinary incontinence, which is a condition involving involuntary loss of urine, is a problem with very many patients, particularly female patients, throughout the world. Sometimes the problem is treated with surgery. However, when the patient can not receive surgery or suffers only from a partial loss of urine, the problem may be treated non-surgically by use of an internal (intra-urethral or intra-vaginal) or external device. A number of external female devices have been proposed in the art.
For example, U.S. Pat. No. 5,074,855 discloses a device for controlling urinary incontinence in a human female comprising a resilient pad configured to seal against and occlude the urethral meatus of the user. A similar device is disclosed in U.S. Pat. No. 5,336,208. In both these devices, an adhesive is provided to seal the body of the device against the urethral meatus.
International Applications No. 96/39989, 96/39990 and 96/39991 each disclose a adfemale urinary incontinence device in the form of a urethral cap with a partially deformable body portion, a hand gripping portion and a body contacting surface. The body portion defines a chamber which allows for a vacuum seal when applied to the patient""s body.
Each of the above devices prevents urinary leakage by occluding the external urethral orifice and each has to be removed by the patient to allow micturition.
It is desirable to have a device which satisfactorily prevents leakage and also facilitates micturition without the need to remove the device from the body of the patient. It has now been found that these desiridata may be achieved by a device which incorporates an easily operable valve which prevents leakage when closed and allows flow when open.
According to the invention there is provided a device for treating leakage from an external orifice in the body of a patient, which device comprises a first member having a body contacting first surface and an opposing second surface about an aperture, which first surface is attachable to the body of the patient with- said aperture positioned over said orifice, and a second member integral with said second surface, which second member comprises a valve mounted over said aperture, which valve has a closed position which prevents leakage of fluid through the device and an open position which allows fluid from said orifice to flow through said aperture when desired, the closed and open positions being achievable without removing the device from the body of the patient.
When the external orifice is a urethral orifice the fluid is urine and accordingly the invention provides, as a preferred embodiment, a device for alleviating urinary incontinence in a patient having an external urethral orifice, which device comprises a first member having a body-contacting first surface and an opposing second surface about an aperture, which first surface is attachable to the patient with said aperture positioned over said urethral orifice, and a second member integral with said second surface, which second member comprises a valve mounted over said aperture, which valve has a closed position which prevents leakage of urine through the device and an open position which allows urine from said urethral orifice to flow through said aperture upon micturition, the closed and open positions being achievable without removing the device from the patient.
In a further preferred embodiment at least a portion of said first surface is coated with a biologically-compatible adhesive, i.e. a medical adhesive, to facilitate attachment of the surface to the body, e.g. the floor of the labial vestibule around the urethral meatus, of the patient.
A particularly preferred embodiment of the invention is a device as described above for alleviating urinary incontinence in a female patient, in which said first member is a substantially circular or oval shaped flange having a first surface at least a portion of which is coated with a biologically-compatible adhesive so that said first surface is attachable to the floor of the labial vestibule, and said valve is defined by a foldable extension of the flange, which extension forms two foldable flaps having a closed position wherein the flaps are folded inwardly to form a closure over the aperture and an open position wherein the flaps extend outwardly to define a flow path from the aperture to the exterior.
The valve of the invention may have any one of a number of different configurations.
In each preferred version of the valve, the aperture is preferably funnel-shaped and the wall of the funnel is defined by the first surface of the flange. However, the positioning of the portions of the flange which act upon the foldable flaps to effect closure of the valve, each of which is herein designated as a xe2x80x9cpincherxe2x80x9d, relative to the other portions, differs in the various versions. The configuration of the portions which make up the valve and the foldable flaps thereof and the spatial relationship of these portions with respect to each other is described in detail hereinafter with reference to the embodiments illustrated in the accompanying drawings.
Each foldable flap of the valve is preferably made of a material which is sufficiently elastic to be folded and compressed or pinched a number of times without deterioration and the preferred material is a biologically compatible elastomer. Typically all components of the device are integral with each other and are made from the same elastomeric material.
A device suitable for a male patient is also included within the invention, and in this embodiment the first member will have the shape of a short condom instead of a flange.
Additionally the invention also encompasses an embodiment which may be used to control leakage from a body stoma and allow drainage therefrom when desired. The components of such an embodiment are analogous to those of the herein described embodiments for alleviating urinary incontinence.